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EC number: 701-473-2 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
acute oral: The LD50 in female rats is reported to be >2000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 May 2018 - 18 June 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17 December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- December 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: in house bred, Animal Facility, Bioneeds India Private Limited Devarahosahally, Sompura Hobli, Nelamangala Taluk, Bangalore Rural District, PIN - 562 111, Karnataka, India
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 to 10 weeks
- Weight at study initiation: 160.39 g to 176.55 g
- Housing: max. 3 animals per cage in standard polypropylene cage
- Diet: ad libitum, Altromin Maintenance diet for rats and mice 1324 manufactured by Altromin Spezialfutter GmbH & Co. KG
- Water: ad libitum, deep bore-well water passed through reverse osmosis unit was provided in plastic water bottles with stainless steel sipper tubes
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19.6 to 22.9°C
- Humidity: 43 to 65%
- Air changes: 12 to 15 per hr
- Photoperiod: 12 / 12 hrs dark / hrs light - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Step I 30 mg/mL and Step II 200 mg/mL
- Amount of vehicle: 0.5% w/v Carboxy Methyl Cellulose (CMC)
- Justification for choice of vehicle: 0.5% w/v CMC is universally accepted and routinely used vehicle in oral toxicity studies. - Doses:
- 300 mg/kg bw (Step I) and 2000 mg/kg bw (Step II)
- No. of animals per sex per dose:
- 3 females per Step and dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All the animals were observed for clinical signs of toxicity and mortality at 30 to 40 min, 1 hr (±10 min), 2 hrs (±10 min), 3 hrs (±10 min) and 4 hrs (±10 min) post dosing on Day 1 and at least once daily thereafter for clinical signs of toxicity throughout the
experimental period. Individual animal body weight was recorded at receipt, on day 1 before test item administration and on day 8 and 15 during the observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, observations included changes in skin, fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern - Statistics:
- None
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- In Step-I and Step-I confirmation, the animals were dosed with 300 mg/kg body weight. No mortality was observed.
In Step-II and Step-II confirmation, the animals were dosed with 2000 mg/kg body weight. No mortality was observed. - Clinical signs:
- other: No clinical sigsns were observed.
- Gross pathology:
- No gross pathological changes were observed in any of the animals dosed at 300 mg/kg and 2000 mg/kg body weight.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the experiment, it is concluded that the LD50 for the test item is > 2000 mg/kg body weight when administered as a single dose by oral gavage to female Sprague Dawley rats.
- Executive summary:
The test item was evaluated for acute oral toxicity in Sprague Dawley rats according to OECD Guideline No. 423: Acute Oral Toxicity - Acute Toxic Class Method adopted on 17 December 2001. A starting dose of 300 mg/kg body weight was selected from the fixed dose levels of 5, 50, 300 and 2000 mg/kg body weight as there was no available information on the LD50 of the test item.
A total of 12 females (3 females each for each Step-I, Step-I confirmation, Step-II and Step-II confirmation) were used for the experiment. All then animals of Step-I and Step-I confirmation were administered with 300 mg/kg body weight of the test item and Step II and Step II confirmation were administered with 2000 mg/kg body weight of the test item by oral route.
All the animals were observed for clinical signs of toxicity and mortality at 30 to 40 min, 1 hr (±10 min), 2 hrs (±10 min), 3 hrs (±10 min) and 4 hrs (±10 min) post dosing on day 1 and once daily thereafter for clinical signs of toxicity and twice daily for mortality during the 14 days observation period. Body weight was recorded on day 1 before test item administration and on day 8 and 15 during the observation period. At the end of observation period, all the surviving animals were sacrificed under carbon dioxide anaesthesia, subjected to necropsy and gross pathological examination.
In Step-I and Step-I confirmation, the animals dosed with 300 mg/kg body weight did not reveal any clinical signs of toxicity and mortality. In Step-II and Step-II confirmation, the animals dosed with 2000 mg/kg body weight did not reveal any clinical signs of toxicity and mortality.
No changes were observed in body weight and percent change in body weight with respect to day 1 at 300 mg/kg and 2000 mg/kg body weight. All the animals revealed physiologically normal increase in the body weight.
No gross pathological changes were observed in any of the animals dosed at 300 mg/kg and 2000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP study according OECD TG 423
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral
The test item was evaluated for acute oral toxicity in Sprague Dawley rats according to OECD Guideline No. 423: Acute Oral Toxicity - Acute Toxic Class Method adopted on 17 December 2001. A starting dose of 300 mg/kg body weight was selected from the fixed dose levels of 5, 50, 300 and 2000 mg/kg body weight as there was no available information on the LD50 of the test item.
A total of 12 females (3 females each for each Step-I, Step-I confirmation, Step-II and Step-II confirmation) were used for the experiment. All then animals of Step-I and Step-I confirmation were administered with 300 mg/kg body weight of the test item and Step II and Step II confirmation were administered with 2000 mg/kg body weight of the test item by oral route.
All the animals were observed for clinical signs of toxicity and mortality at 30 to 40 min, 1 hr (±10 min), 2 hrs (±10 min), 3 hrs (±10 min) and 4 hrs (±10 min) post dosing on day 1 and once daily thereafter for clinical signs of toxicity and twice daily for mortality during the 14 days observation period. Body weight was recorded on day 1 before test item administration and on day 8 and 15 during the observation period. At the end of observation period, all the surviving animals were sacrificed under carbon dioxide anaesthesia, subjected to necropsy and gross pathological examination.
In Step-I and Step-I confirmation, the animals dosed with 300 mg/kg body weight did not reveal any clinical signs of toxicity and mortality. In Step-II and Step-II confirmation, the animals dosed with 2000 mg/kg body weight did not reveal any clinical signs of toxicity and mortality.
No changes were observed in body weight and percent change in body weight with respect to day 1 at 300 mg/kg and 2000 mg/kg body weight. All the animals revealed physiologically normal increase in the body weight.
No gross pathological changes were observed in any of the animals dosed at 300 mg/kg and 2000 mg/kg body weight. Based on the results of the experiment, it is concluded that the LD50 for the test item is > 2000 mg/kg body weight when administered as a single dose by oral gavage to female Sprague Dawley rats.
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. Based on
available data on acute toxicity, the
test substance is not classified for acute oral toxicity according
to Regulation (EC) No 1272/2008 (CLP), as amended for
the twelfth time in Regulation (EU) No 2019/521.
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